“Negligible likelihood” AquaBounty salmon cause any effects on the environment of the U.S.

AquaBounty salmon swimming in a grow-out tank. Photo: AquaBounty Technologies.
AquaBounty salmon swimming in a grow-out tank. Photo: AquaBounty Technologies.

Following a 2020 court ruling, the US Food and Drug Administration (FDA) has re-examined the risks that AquaBounty's genetically modified salmon farming could pose to the environment. The draft submitted this month concludes that the combination of all the safety measures taken by the company "results in a negligible likelihood that any eggs or fish of any life stage of ABT salmon could escape into the wild and cause effects on the environment of the US", as the now-revised 2015 report already noted.

Extremely unlikely occurrence

"AquaBounty raises fresh Atlantic salmon in a safe, secure, and sustainable way. The likelihood of our salmon escaping our land-based farms, surviving, and establishing a population in the wild is 'extremely low'. Those are FDA's words in its first review issued in 2015, and in the amended Environmental Assessment released on November 16, the FDA once again concluded there is a 'negligible likelihood' that our product would 'cause significant harms' or even ANY 'effects on the environment of the US'". This is how Sylvia Wulf, CEO of AquaBounty sums up her impressions following the release of the FDA's draft modified environmental assessment.

The fact is that in the likelihood rankings for exposure analysis defined by the FDA, the category of 'negligible likelihood' is defined as "extremely unlikely or not reasonably foreseeable occurrence", and it is clarified that here, "negligible is synonymous with minimal, de minimus, very low and extremely low". So, it is not surprising that, despite the fact that a virtual public meeting is still pending to review this draft, Wulf is calm.

Sylvia Wulf, CEO of AquaBounty Technologies

"We are continuing to review FDA's amended Environmental Assessment and are confident this process will affirm the extremely low likelihood that our salmon could successfully establish a population in the wild", said Wulf. "We look forward to having this matter quickly settled and, in the meantime, we will continue to focus on sharing our sustainable, nutritious salmon with our customers".

Highly controlled land-based farms

"Our highly controlled land-based farms and robust mitigation measures – already approved by federal regulators and in use without issue in our facilities for over 20 years – help prevent any impacts, however unlikely, to the environment, endangered species, or wild fish populations", Wulf also said. "Additionally, our AquaBounty production salmon are female, sterile, and unable to reproduce, providing an additional and redundant biological barrier to protect wild salmon", she added.

Indeed, in its draft modified environmental assessment for AquaBounty, the U.S. Food and Drug Administration states that "FDA continues to conclude that, as a result of multiple and redundant forms of effective physical and procedural containment at the Bay Fortune and Rollo Bay facilities, the likelihood of escape of any life stage or type of ABT Salmon is negligible".

As previously said, a virtual public meeting is still pending for next December 15. However, the FDA has already warned that this meeting will not become a discussion on AquaBounty in general, but will focus exclusively on the modified draft environmental assessment. "The purpose of the public comment period and virtual public meeting is to obtain input from the public on the draft amended EA, and whether the information and analysis presented is accurate and complete", they said.

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